Making Sense of the FDA’s Real World Data Program

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Since the passage of the 21st Century Cures Act (aka Cures Act) in 2016, the FDA has been releasing new protocols and programs to expedite the approval process for new medical drugs and devices. One such new program is the Real-world Evidence (RWE) program that allows for the use of data collected outside of clinical trials to be incorporated into research submitted for FDA approval. In December 2018, the FDA published a framework for the RWE program in which they delineate the potential of RWE to support the approval of new indications for products already on the market, and post-approval study requirements. 

 

The use of RWE can be beneficial throughout the entire research and development process of new drugs and devices, provided it appears as though it was generated through a randomized clinical trial. The fact of the matter is, as technology advances, pharmaceutical companies and the FDA are looking to become more advanced as well. The real world data program will become a winning scenario for everyone. For drug developers, it will mean more accurate data meaning the FDA will be able to make more informed decisions. This means drugs and devices that reach the consumer will have more data to support their use. In order to better illustrate the potential implications of RWE throughout the research and development process, we have created an infographic that demonstrates the role RWE can play in each phase.

Should You Care About Real World Data?

While RWD has the potential to save drug developers money in the long term, many are unsure about how to properly use this data in submissions. If you are in the process of seeking FDA approval for your medical device or product understanding the advantages of this data and FDA guidance should be a high priority. Our E-Book provides an in-depth analysis, answering the essential questions for using RWD and our infographic is an easily digestible timeline for how RWD can fit into your clinical trials and phases of your drug development. 

Moving forward, the implementation of RWE will become more and more common, and the logistics of seeking approval with RWE will become clearer. Staying current with industry knowledge can give your development team the edge to make it to market quickly. Download our E-Book and Infographic PDFs today.

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